Excision of a segment of diseased colon or intestine and subsequent anastomosis of the cut end portions is known in the art. Such excision and anastomosis can be carried out by entering the abdominal cavity using either open surgery or a laparoscopic procedure. However, there are significant problems associated with these procedures.
The integrity of the anastomosis must be sound so that there is no risk of the anastomosis rupturing or leaking into the abdominal cavity. Opening the bowel lumen and exposing the clean abdominal cavity to contamination increases the risk of postoperative infection. There have been a number of improvements in anastomosis procedures over the past decade. These improvements can be found inter alia in U.S. Pat. No. 5,197,648 to Gingold; U.S. Pat. No. 5,312,024 to Grant, et al.; U.S. Pat. No. 5,344,059 to Green, et al.; U.S. Pat. No. 5,411,508 to Bessler, et al.; and U.S. Pat. No. 5,639,008 to Gallagher, et al.
In order to avoid opening the bowel lumen and exposing the clean abdominal cavity to endoluminal contents, intussusception of the colon or intestine may be employed. Intussusception enables the excision to be conducted within an apparatus preventing contamination of the body cavity. There has been a development recently whereby the intussusception, anastomosis and resection of the intussuscepted segment is facilitated by an apparatus and method discussed in U.S. Pat. No. 6,117,148 to Ravo et al.
Each of the foregoing inventions utilizes stapling for achieving anastomosis of the portions of bowel or intestine to be joined. It would be advantageous to utilize a procedure and apparatus that did not rely on applying a plurality of staples or other connecting devices, which, of necessity, remain in the bowel and which, despite the utmost care by the surgeon, may leak or rupture.
Surgical fastening clips are known in the art. The clips apply a clamping force to a site, such as a blood vessel, thereby reducing its cross-sectional area. Surgical fastening clips known in the art are sometimes formed of a shape-memory alloy which deform to a closed configuration when heated. The clamping force applied by the clip is increased as it is heated. Typical surgical clips are discussed in, for example, U.S. Pat. No. 5,171,252 to Friedland; EP 0,326,757 to Fujitsuka Tatsuo; and SU 1,186,199 to Makarov et al.
A major disadvantage of known shape-memory alloy clips is that they permit compression of only approximately 80-85% of the junction perimeter. This requires the use of additional manual sutures, which reduce the integrity of the seal of the junction during the healing period and its elasticity during the post-operative period. Additional suturing is also problematic since it has to be carried out across a join which includes a portion of the clip, thereby rendering difficult the sealing and anastomosis of the organ portions. Furthermore, once in place, prior art clips require further surgery to be performed, namely, incisions through tissue so as to create a passageway between the two organ portions which have been joined by the clip. This is further discussed in U.S. Pat. No. 6,402,765 to Monassevitch et al. and U.S. Pat. No. 6,896,684 to Monassevitch et al.
The surgical clip and the anastomosis clip applicator device, recited in U.S. Pat. No. 6,402,765 and U.S. Pat. No. 6,896,684 respectively, relate to a shape-memory alloy clip insertable through apertures formed in the side-walls of a pair of adjacent hollow organ portions utilizing an anastomosis clip applicator device. Access to the hollow organ is generally extra-tubular, that is, achieved by means of open surgery or a laparoscopic procedure during which access to the organ parts results in the risk of exposure of the abdominal cavity to contamination from the excised or severed organ. Furthermore, the nature of the anastomosis provides a join of the organ portions through the adjacent side-walls. Generally, a join formed of the in-line excised ends is preferred. This arrangement avoids the possibility of resistance to or reduction in the flow through the anastomosed adjacent organ portions.
Recently, U.S. Pat. No. 6,884,250 to Monassevitch et al. and U.S. patent application Ser. No. 10/237,505 to Monassevitch et al. describe endoluminal intussusception and anastomosis devices which apply surgical clips to an intussuscepted and anastomosed region of a lumen with the clip being delivered endoluminally. The apparatuses described in these documents have, in practice, a limiting minimum external diameter which substantially restricts their application.
Other forms of clips and/or anastomosis devices are discussed in U.S. Pat. No. 4,957,499 to Lipstov et al.; U.S. Pat. Nos. 4,476,863 and 4,567,891 to Kanshin et al.; Soviet Pat. No. SU 79-00049 to Kanshin et al.; U.S. Pat. No. 4,505,272 to Utyamshev et al.; and Wullstein et al. Compression anastomosis (AKA-2) in colorectal surgery: results in 442 consecutive patients; British Journal of Surgery, (2000) 87, 1071-1075, Blackwell Science Ltd. 2000. In these publications the force used to effect anastomosis is not necessarily constant and is dependent on the thickness of the tissue of the organ to undergo anastomosis. Accordingly, the resulting join is weak or incomplete.
Therefore, there still exists a need for a surgical apparatus which allows for endoluminal insertion into organ lumens, including transanal insertion, as well as insertion into small lumens, such as that of the esophagus. Such endoluminal insertion would obviate the need for additional surgical procedures, such as enterotomies, which are often accompanied by manual sutures. This would greatly assist in a smooth robust seal of the wound junction during the healing period, as well as preserve its elasticity during the post-operative period.